Model Number 10010454 |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that gem 20d v/nv ntg.2mf 1ss dehp free had flow issues and was clogged.The following information was provided by the initial reporter: "patient was receiving iv chemotherapy consisting of etoposide, vincristine and doxorubicin per epoch regimen.Iv filter is being used to prevent precitates from etoposide from passing through.Filter became saturated and chemotherapy began leaking out.".
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Manufacturer Narrative
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H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the filter became saturated and start leaking could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
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Event Description
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It was reported that gem 20d v/nv ntg.2mf 1ss dehp free had flow issues and was clogged.The following information was provided by the initial reporter: "patient was receiving iv chemotherapy consisting of etoposide, vincristine and doxorubicin per epoch regimen.Iv filter is being used to prevent precitates from etoposide from passing through.Filter became saturated and chemotherapy began leaking out.".
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Search Alerts/Recalls
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